Coping Skills Training (CST) for Children With Chronic Health Conditions - Full Text View

Sponsors and Collaborators:	Children's Hospital and Health System Foundation, Wisconsin University of Wisconsin, Madison
Information provided by:	Children's Hospital and Health System Foundation, Wisconsin
ClinicalTrials.gov Identifier:	NCT00359775

Purpose

Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12 years of age and their parents. The participants in this study at Children's Hospital of Wisconsin are dealing with one of three chronic health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma).

Research Questions/Study Aims

The research questions addressed in the full study are:

What is the impact of CST on child depression, QOL, health motivation, attitude toward illness, and self-management efficacy?
What is the impact of CST on parent depression, perception of child's quality of life, perception of impact of CHC on family, and family conflict?

Condition	Intervention	Phase
Rheumatologic Conditions Epilepsy Spina Bifida	Behavioral: Coping Skills Training	Phase II

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Asthma Depression Epilepsy Spina Bifida

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Coping Skills Training (CST) for Children With Chronic Health Conditions: An Extension From Children With Diabetes to Children With Rheumatologic Conditions, Epilepsy, Spina Bifida, and Asthma

Further study details as provided by Children's Hospital and Health System Foundation, Wisconsin:

Primary Outcome Measures:

Child Depression measured by Child Depression Inventory (CDI) [ Time Frame: ongoing ] [ Designated as safety issue: No ]
Parent Depression measured by Beck Depression inventory (BDI) [ Time Frame: ongoing ] [ Designated as safety issue: No ]
Quality of life measured by Child Health Questionnaire [ Time Frame: ongoing ] [ Designated as safety issue: No ]
Impact on Family measured by the Impact of Family Scale. [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

6 session behavioral program

Detailed Description:

Many children with chronic health conditions (CHC) are at increased risk for poor adaptation such as psychosocial problems, behavioral disturbances, and decreased quality of life (QOL). Their parents face economic, social and emotional challenges. In addition, management of the CHC and the involvement of the child in that management can severely challenge both child and parent. Effective coping has been shown to moderate the negative impact of CHC. This study is a pilot study to evaluate the feasibility and preliminary efficacy of adapting a Coping Skills Training (CST) intervention developed for children with diabetes. The CST intervention will be adapted for an integrated sample of school-aged children 8 to 12 years of age with four health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma). The study will be a randomized clinical trial with a wait-list control group. Each arm will consist of 25 families. CST is a 6-session group intervention based on cognitive behavioral and learning theory. The impact of CST on both outcomes (child: depression, QOL; parent: depression, Child QOL, CHC impact on family) and protective factors (child: health motivation, attitude, self-management efficacy; parent: family conflict) will be measured.

Eligibility

Ages Eligible for Study:	8 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female children ages 8 to 12 with no known severe cognitive delays,
Who are English speaking,
With one of the three target conditions; and
Have at least one parent willing to participate.

Exclusion Criteria:

Children with cognitive delay

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359775

Contacts

Contact: Betsy l. Roth-Wojcicki, MS, CPNP	414-266-6762	broth-wojcicki@chw.org
Contact: Kathleen J Sawin, DSN, CPNP	414-266-3615	ksawin@chw.org

Locations

United States, Wisconsin
Children's Hospital of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53201
Principal Investigator: Betsy Roth-Wojcicki, MS, CPNP
Principal Investigator: Kathleen J. Sawin, DSN,CPNP
Sub-Investigator: Mary Kay Balchunas, MTS,MAW
Sub-Investigator: Gayle Kazierczak, MS
Sub-Investigator: Renee Ladwig, APRN,BC,LMFT
Sub-Investigator: Heidi Miranda, MS,CCLS
Sub-Investigator: Lois Pearson, M.Ed,CCLS
Sub-Investigator: Karen Rauen, MSN
Sub-Investigator: Susan Sorge, BS
Sub-Investigator: Rhonda Roell Werner, MSN
Sub-Investigator: Dawn Zahrt, PhD

Sponsors and Collaborators

Children's Hospital and Health System Foundation, Wisconsin

University of Wisconsin, Madison

Investigators

Principal Investigator:	Betsy Roth-Wojcicki, MS, CPNP	Medical College of Wisconsin/Children's Hospital of Wisconsin
Principal Investigator:	Kathleen Sawin, DNS, CPNP,	University of Wisconsin Milwaukee/Children's Hopsital of Wisconsin

More Information

Responsible Party:	Children's hospital of WI ( Betsy roth-wojcicki RN,MS,CPNP )
Study ID Numbers:	CHW 06/32,GC 95, UWM # 06-02-208
Study First Received:	July 31, 2006
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00359775
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital and Health System Foundation, Wisconsin:

Coping
psychosocial
Quality of Life
problem solving

Study placed in the following topic categories:

Neural Tube Defects
Nervous System Malformations
Spinal Dysraphism
Epilepsy
Spina bifida
Diabetes Mellitus

Quality of Life
Central Nervous System Diseases
Asthma
Neural tube defect, folate-sensitive
Congenital Abnormalities
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009